SUPRA SULFA III- sulfamethazine tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SULFAMETHAZINE (UNII: 48U51W007F) (SULFAMETHAZINE - UNII:48U51W007F)

Available from:

Aspen Veterinary Resources

INN (International Name):

SULFAMETHAZINE

Composition:

SULFAMETHAZINE 32.1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Supra Sulfa® III Boluses (sulfamethazine) are intended for oral administration to beef cattle and non-lactating dairy cattle (See RESIDUE WARNING Statement) . Supra Sulfa® III Boluses are indicated for the treatment of the following diseases when caused by one or more of the following pathogenic organisms sensitive to sulfamethazine: Bacterial Pneumonia and Bovine Respiratory Disease Complex (Shipping Fever Complex) (Pasteurella spp.), Colibacillosis (Bacterial Scours) (E. Coli ), Necrotic pododermatitis (Foot Rot), Calf Diphtheria (Fusobacterium necrophorum ), Acute Metritis (Streptococcus spp.).

Authorization status:

New Animal Drug Application

Summary of Product characteristics

SUPRA SULFA III- SULFAMETHAZINE TABLET, EXTENDED RELEASE
ASPEN VETERINARY RESOURCES
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SUPRA SULFA III
(SULFAMETHAZINE)
SUSTAINED RELEASE BOLUS (72 HOURS)
ANTIBACTERIAL
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
NOT FOR HUMAN USE
KEEP OUT OF REACH OF CHILDREN
Approved by FDA under NADA # 120-615
NET CONTENTS: 50 BOLUSES
EACH BOLUS CONTAINS: Sulfamethazine (formulated in a sustained release
base),
495 grains (32.1 grams)
Supra Sulfa III Boluses (sulfamethazine) are intended for oral
administration to beef
cattle and non-lactating dairy cattle (SEE RESIDUE WARNING STATEMENT).
Supra
Sulfa III Boluses are indicated for the treatment of the following
diseases when caused
by one or more of the following pathogenic organisms sensitive to
sulfamethazine:
Bacterial Pneumonia and Bovine Respiratory Disease Complex (Shipping
Fever Complex)
(_Pasteurella_ spp.), Colibacillosis (Bacterial Scours) (_E. Coli_),
Necrotic pododermatitis (Foot
Rot), Calf Diphtheria (_Fusobacterium necrophorum_), Acute Metritis
(_Streptococcus_ spp.).
RESIDUE WARNING: Treated animals intended for human consumption should
not be
slaughtered for food for at least 12 days after the last dose.
Exceeding two (2)
consecutive doses may cause violative tissue residues to remain beyond
the withdrawal
time. Do not use in female dairy cattle 20 months of age or older. Use
of sulfamethazine
in this class of cattle may cause milk residues. Do not use in calves
under one (1) month
of age or calves being fed an all-milk diet. Use in these classes of
calves may cause
violative residues to remain beyond the withdrawal time.
CAUTION: This drug, like all sulfonamides, may cause toxic reactions
and irreparable
injury unless administered with adequate and continuous supervision;
FOLLOW
RECOMMENDED DOSAGES CAREFULLY.
Fluid intake must be adequate at all times throughout the three-day
therapy provided by
the sustained release bolus. This product has not been shown to be
effective for non-
ruminating calves.
DOSA